The FDA is proposing to establish additional traceability requirements to mitigate foodborne illnesses. Learn about the new Critical Tracking Elements that might affect your food safety plan and how your record-keeping will need to change. This presentation covers details of the proposal and timelines for public comment and implementation, as well as provide an update on October's FDA regulation changes.

1. FSMA Fridays Webinar Series
Monthly Industry News, Updates & Trends for Food, Beverage, & CPG Manufacturers
Understanding the FDA's Proposed
Rule for Food Traceability
with Eric Edmunds, JD
October 30, 2020

2. Monthly Industry Update:
✔ FSMA Related News
✔ Regulation Changes & Updates
✔ Industry Trends
✔ Q&A with TAG
What is FSMA Fridays?
FSMA FRIDAYS

3. Casual but Professional Format
✔ Ask questions! (Q&A at end)
✔ Only panelists are displayed
✔ Recording link will be shared
✔ Audio issues: use call-in number
Watch prior FSMA Friday recordings at
safetychain.com > Resources > FSMA Fridays
Before We Get Started
FSMA FRIDAYS

4. Featured Panelist & Host
FSMA FRIDAYS
Eric Edmunds, JD
Director of Food Safety
● Brings a combination of legal, regulatory
and food industry experience to TAG and
FSMA Fridays
● Certified in HACCP, is a Registered
Environmental Health Specialist with
NEHA, and a FSMA Preventive Controls
Qualified Individual for Human Food
Aaron Bolshaw
VP Marketing

5. FSMA FRIDAYS
The Latest FSMA Updates
• Voluntary Pilot Program to Evaluate Third-Party Food Safety Standards
• Remote Training for Intentional Adulteration Vulnerability Assessment
… and today’s topic,
FDA’s Proposed Rule for Food Traceability

6. FSMA FRIDAYS
FDA's Proposed Rule for Food Traceability
Overview
1. Affected Foods & Ingredients
2. Define Key Terms (CTEs, KDEs, etc.)
3. Rules for Growers, Receivers, Transformers,
Creators, and Shippers
4. Kill Step Requirements
5. Record Maintenance & Availability
6. Timelines & Enforcement

7. FSMA FRIDAYS
Food Traceability List (FTL)
Cheeses, other than hard cheeses
Shell eggs
Nut butters
Cucumbers
Herbs (fresh)
Leafy greens, including fresh-cut leafy greens
Melons
Peppers
Sprouts
Tomatoes
Tropical tree fruits
Fruits and Vegetables (fresh-cut)
Finfish, including smoked finfish
Crustaceans
Mollusks, bivalves
Ready-to-eat deli salads

8. FSMA FRIDAYS
Defining Key Terms
• Critical Tracking Event (CTE)
• Key Data Element (KDE)
• Reference Record
• Traceability Lot Code
• Traceability Product Description
• Differences between single-ingredient and
multiple-ingredient products

9. FSMA FRIDAYS
General Records - Overview
• List & describe reference records. How are reference records linked?
• State where on the records to find new requirements.
• Provide a list of foods on FTL that you ship, including the traceability
product identifier and traceability product description
• Tell how you establish and assign traceability lot codes
• Include other information needed to understand the data provided in
any records (e.g. coding systems, glossaries, abbreviations)

10. FSMA FRIDAYS
Records for Growers
• Establish and maintain records containing
and linking the traceability lot code to:
Growing area coordinates
• Note: Additional KDEs for growers of
sprouts

11. FSMA FRIDAYS
Records for Receivers
• Establish and maintain records containing and
linking the traceability lot code to:
• The location identifier and location description for the immediate
previous source
• Entry number assigned to food (if imported)
• The location identifier and location description of where the food
was received, and the date and time the food was received
• The quantity and unit of measure of the food
• The traceability product identifier and traceability product
description for the food
• The location identifier, location description, and point of contact
for the traceability lot code generator
• The reference record types and numbers for documents
containing the information
• The name of the transporter who transported you the food

12. FSMA FRIDAYS
Records for First Receivers
• The first person (other than a farm) who purchases and takes physical possession of a listed
food
• Traceability lot code
• Location identifier and location description of originator of food
• Business name/phone number/point of contact of harvester of food (including date
and time of harvest)
• Location identifier and location description of the place the food was cooled
(including date and time of cooling)
• Location identifier and location description of the place where the food was packed
(including date and time of packing)
• Seafood obtained from a fishing vessel
• Traceability lot code
• Harvest date range and locations for the trip during which seafood was caught

13. FSMA FRIDAYS
Records for Transformers
• When a food, package or label is
changed
• Combining ingredients, processing (cutting,
cooking, commingling, repacking, or
repackaging)
• Differentiates foods used in
transformation from food produced
through transformation (slightly
different rules)

14. FSMA FRIDAYS
Records for Creators
• Location identifier and location (where created, date complete)
• Traceability product identifier and product description
• Quantity and unit of measure of the food
• Reference record types and reference record numbers
• Note: Does not apply to retail establishments with respect to foods they
do not ship (e.g. foods they sell or send directly to consumers)

15. FSMA FRIDAYS
Records for Shippers
• Entry number assigned (if imported)
• Quantity and unit of measure of the food
• Product identifier and product description
• Location identifier, location description, and point of
contact for the traceability lot code generator
• Location identifier and location description for the
immediate subsequent recipient (other than a
transporter)
• Location identifier and location description for the
location from which you shipped the food, and the date
and time you shipped the food
• Reference record types and numbers
• The name of the transporter who transported the food
from you

16. FSMA FRIDAYS
What if There’s a Kill Step?
• If you apply a kill step, the requirements do
not apply to your subsequent shipping
• Need to keep records of your kill step
• If you receive a food that has been subject to
a kill step, the requirements do not apply to
your receipt or subsequent transformation
and/or shipping of food

17. FSMA FRIDAYS
Record Maintenance and Availability
• Provide records ASAP but not > 24 hours after request
• If necessary to help the FDA prevent or mitigate a foodborne illness
outbreak, assist in implementation of a recall, or otherwise address a
threat to public health
• Must make available an electronic sortable spreadsheet containing the information in
the records required under the rule

18. FSMA FRIDAYS
Timelines & Enforcement
• Proposed rule now available for public comment until Jan. 21, 2021
• Final rule would become effective 60 days after it is published in the Federal Register
• Enforcement: Compliance date will be the same for all persons subject to the
recordkeeping requirements would be 2 years after the effective date of the final
regulation. https://www.fda.gov/media/142303/download
• Exemptions and modified requirements:
see https://www.fda.gov/media/142302/download

19. Q & A
FSMA FRIDAY

20. ✔ FSMA Friday Session Recordings & Content Library
✔ TAG Newsletter
✔ Global Food Safety Consultants
AchesonGroup.com
✔ FSMA Friday LinkedIn Group
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Resources & Future Events
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November 20, 2020:
Labeling Changes (Eric Edmunds)

21. FSMA FRIDAYS
Food Traceability List - Reference
Foods Description
Cheeses, other than hard cheeses Includes all soft ripened or semi-soft cheeses, and fresh soft cheeses that are
made with pasteurized or unpasteurized milk
Shell eggs Shell egg means the egg of the domesticated chicken
Nut butter Includes all types of tree nut and peanut butters; does not include soy or seed
butters
Cucumbers Includes all varieties of cucumbers
Herbs (fresh) Includes all types of herbs, such as parsley, cilantro, basil
Leafy greens, including fresh-cut leafy greens Includes all types of leafy greens, such as lettuce, (e.g., iceberg, leaf and
Romaine lettuces), kale, chicory, watercress, chard, arugula, spinach, pak choi,
sorrel, collards, and endive
Melons Includes all types of melons, such as cantaloupe, honeydew, and watermelon
Peppers Includes all varieties of peppers

22. FSMA FRIDAYS
Food Traceability List (Reference - cont’d)
Foods Description
Sprouts Includes all varieties of sprouts
Tomatoes Includes all varieties of tomatoes
Tropical tree fruits Includes all types of tropical tree fruit, such as mango, papaya, mamey,
guava, lychee, jackfruit, and starfruit
Fruits and Vegetables (fresh-cut) Includes all types of fresh-cut fruits and vegetables
Finfish, including smoked finfish Includes all finfish species, such as cod, haddock, Alaska pollack, tuna, mahi
mahi, mackerel, grouper, barracuda, and salmon; except does not include
siluriformes fish, such as catfish [1]
Crustaceans Includes all crustacean species, such as shrimp, crab, lobster, and crayfish
Mollusks, bivalves Includes all species of bivalve mollusks, such as oysters, clams, and mussels;
does not include scallop adductor muscle.
Ready-to-eat deli salads Includes all types of ready-to-eat deli salads, such as egg salad, potato salad,
pasta salad, and seafood salad; does not include meat salads

23. FSMA FRIDAYS
Key Terms Reference
• Critical Tracking Event (CTE) – An event in the supply chain of a food
involving the growing, receiving (including first receipt by a first
receiver), transforming, creating or shipping of food
• Key Data Element (KDE) – Information associated with a critical
tracking event for which a record must be established and maintained
in accordance with this subpart
• Reference Record – A record used to identify an event in the supply
chain of a food, such as a shipping, receiving, growing, creating, or
transformation event. Types of records include, but are not limited to,
bills of lading, purchase orders, advance shipping notices, work orders,
invoices, batch logs, production logs, and receipts.

24. FSMA FRIDAYS
Key Terms Reference, cont’d
• Traceability Lot Code – A descriptor, often alphanumeric, used to
identify a traceability lot
• Traceability Product Description – A description of a food product
typically used commercially for purchasing, stocking, or selling, and
includes the category code or term, category name, and trade
description
• Single ingredient products – Trade description includes the brand
name, commodity, variety, packaging size, and packaging style
• Multiple ingredient products – Trade description includes the brand
name, product name, packaging size, and packaging style

25. FSMA FRIDAYS
General Records - Reference
• A description of reference records in which you maintain required
information
• An explanation of where on the records the required information
appears, and a description of how reference records are linked
• A list of food on the Food Traceability List that you ship, including the
traceability product identifier and traceability product description
• A description of how you establish and assign traceability lot codes to
foods on the Food Traceability List
• Any other information needed to understand the data provided in any
records (e.g. coding systems, glossaries, abbreviations

26. FSMA FRIDAYS
Records for Growers of Sprouts - Reference
• Location identifier and location description of the grower of seeds, seed lot code, date of seed
harvest
• Location identifier and location description of the seed conditioner or processor, seed lot
code, date of conditioning or processing
• Location identifier and location description of the seed packinghouse (including repackers),
seed lot code, date of packing/repacking
• Location identifier and location description of seed supplier
• Description of seeds, including type or taxonomic name, growing specifications, volume, type
of packaging, and antimicrobial treatment
• Seed lot code assigned by seed supplier, including master lot and sub-lot codes, and any new
seed lot code assigned by the sprouter
• Date of receipt of the seed by the sprouter
• For each lot code for seed received by the sprouter, the sprout traceability lote code and date
of production associated with the seed lot code

27. FSMA FRIDAYS
Records for First Receivers
• Establish and maintain records containing and linking the traceability
lot code to:
• The location identifier and location description of the originator of the food
• The business name, point of contact, and phone number of the harvester of the food ,
and the date(s) and time(s) of harvesting
• The location identifier and location description of the place where the food was cooled,
and the date and time of cooling
• The location identifier and location description of the place where the food was packed,
and the date and time of packing
• May need to establish a traceability lot code when an originator has not
assigned a traceability lot code

28. FSMA FRIDAYS
Records for Receivers - Reference
• Establish and maintain records containing and linking the
traceability lot code to:
• The location identifier and location description for the immediate previous source
• Entry number assigned to food (if imported)
• The location identifier and location description of where the food was received, and the date
and time the food was received
• The quantity and unit of measure of the food
• The traceability product identifier and traceability product description for the food
• The location identifier, location description, and point of contact for the traceability lot code
generator
• The reference record types and numbers for documents containing the information
• The name of the transporter who transported you the food

29. FSMA FRIDAYS
Records for Transformers - Reference
• For foods used in transformation
• Traceability lot codes for the food
• Traceability product identifier and traceability product description
• The quantity of each traceability lot of food
• For food produced through transformation
• Location identifier and location description of where you transformed the food, and the date
the transformation was completed
• The new traceability product identifier and traceability product description for food to which
the new traceability lot code applies
• The quantity and unit of measure of the food for each new traceability lot code
• The reference record types and reference record numbers for documents with information

30. FSMA FRIDAYS
Records for Creators - Reference
• Establish and maintain records containing and linking the
traceability lot code to:
• Location identifier and location description of where you created the food, and the date
the creation was completed
• Traceability product identifier and traceability product description
• The quantity and unit of measure of the food
• The reference record types and reference record numbers for documents containing the
information

31. FSMA FRIDAYS
Records for Shippers - Reference
• Establish and maintain records containing and linking the traceability
lot code to:
• Entry number assigned (if imported)
• Quantity and unit of measure of the food
• Traceability product identifier and traceability product description of the food
• Location identifier, location description, and point of contact for the traceability lot code
generator
• Location identifier and location description for the immediate subsequent recipient
(other than a transporter) of the food
• Location identifier and location description for the location from which you shipped the
food, and the date and time you shipped the food
• Reference record types and numbers containing the information
• The name of the transporter who transported the food from you